510(k) · Cleared
ClearedLzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on May 8, 2012 as substantially equivalent to K020368 (Lin-Zhi International, Inc., 2002) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983159 (1998). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 1 generation backK020769 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
- This deviceK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141803 Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK203527 Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −1 | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
| 0 (this device) | K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators… | Lin-Zhi International, Inc. | 2012 | — |
| +1 | K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | Immunalysis Corporation | 2015 | — |
| +2 | K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020368 | Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit) Our reading of the summary gave K020638, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Opiate Enzyme Immunoassay”. | 2002 |
| * | K020769 | Single Analyte Urine Drugs of Abuse Calibrators and ControlsSummary page 2…e 2000 Enzyme Immunoassay (EtA) at a cutoff of 2000 ng/mL is substantially equivalent to the LZI Opiate Enzyme Immunoassay and Opiate Calibrators and Controls (k020638 & k020769) manufactured by Lin-Zhi International, Inc with a cutoff of 300 ng/mL. The LZI Opiate 2000 Enzyme Immunoassay is identical or si… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141803 (Immunalysis Corporation, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K020368.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The LZI Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of morphine in human urine at the cutoff value of 2000 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS…
Read the full statement (209 words)
The LZI Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of morphine in human urine at the cutoff value of 2000 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Opiate 2000 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The LZI Opiate 2000 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120761
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026